Today, ERIC submitted comments to the Maine House Committee on Health Coverage, Insurance and Financial Services regarding Legislative Document 659, which would allow pharmacists to make biosimilar substitutions. The proposed legislation is highly similar to (pun intended) the Arkansas biosimilar substitution bill that we submitted comments on yesterday. As a refresher, these bills would permit prescribers to limit biosimilar substitution, which ERIC supports since it should be within the provider’s discretion what treatment is best for the patient. We were also supportive of the reasonable time period (five business days) for a pharmacist to notify the prescriber of a biosimilar substitution.
Unlike the Arkansas bill, the Maine version uses broad language regarding patient notification (Arkansas would require disclosure of the cost difference specifically). We made note of this and stated in our comments that, “…requiring excessive disclosures could lead to patient unease, which is unwarranted since biosimilars are deemed safe by the FDA.”
Once again, interchangeability is at issue—this bill would only permit substitution to occur if the biosimilar is deemed interchangeable, and currently, no biosimilar has that status. However, to be approved by the FDA, a biosimilar must be proven safe and effective, and it can have no clinically meaningful differences from the existing reference product. Interchangeability is an additional step beyond FDA approval. Therefore, in our comments, we stated, “…requiring [interchangeability] in order for substitution to occur means this legislation, as currently written, will do little to increase cost savings to the health care system.” Instead, we suggested permitting substitution to occur with a patient’s consent if the FDA has approved a biosimilar for a given reference (branded) biologic.
The Committee will hold a hearing on the bill on March 7, and we will continue to work with the State to ensure that unnecessary burdens to biosimilar utilization are not put into place.
Click here to read our comments in their entirety, and please let me know if you have any questions.
Article by Adam Greathouse, Health Care Policy Senior Associate